FDA.reportPublic FDA data

NDC 71335-1000-03 - DESLORATADINE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-1000
Requested NDC
71335-1000-03
Package NDCs from labels
71335-1000-1, 71335-1000-2, 71335-1000-3, 71335-1000-03
Manufacturer
Bryant Ranch Prepack
Effective date
2026-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DESLORATADINE - Bryant Ranch PrepackBryant Ranch Prepack2026-06-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1000-1DESLORATADINE30 in 1 BOTTLETABLET, FILM COATED304
71335-1000-2DESLORATADINE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1000DESLORATADINE TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 2 package rows20240410_f84c8de3-a7d3-4e8b-bfb6-04259e79450a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesloratadineDESLORATADINEMorepen Bio Inc.21174c0f-9204-4c75-b6e6-2f9ada5b535d2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
DESLORATADINEDESLORATADINELupin Pharmaceuticals, Inc.2a90b899-7746-43dc-ac8a-e754428eb30c2026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA078352
ndc (product): 68180-153
rxcui: 349420
spl id: 4b7fefd7-7d54-400c-a7b4-b3fc4ada2eb1
spl set id: 2a90b899-7746-43dc-ac8a-e754428eb30c
unii: FVF865388R
DESLORATADINEDESLORATADINEBryant Ranch Prepackf84c8de3-a7d3-4e8b-bfb6-04259e79450a2026-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA078352
ndc (package): 71335-1000-3
ndc (package): 71335-1000-2
ndc (package): 71335-1000-1
ndc (product): 71335-1000
ndc11 (package): 71335100003
rxcui: 349420
spl id: b62a5a2c-ad72-4010-a6b7-b0f2593011c5
spl set id: f84c8de3-a7d3-4e8b-bfb6-04259e79450a
unii: FVF865388R
DesloratadineDESLORATADINENatco Pharma USA LLCe4db30a5-48e5-4fe3-8793-30b6866f87c12026-04-23Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
DESLORATADINEDESLORATADINEA-S Medication Solutionsa3b61ab9-ec20-4831-b69a-fcd913fce5402026-04-16Warnings, Adverse reactionsExact identifier
application number: ANDA078352
rxcui: 349420
unii: FVF865388R
DESLORATADINEDESLORATADINEA-S Medication Solutions69b9635b-c790-4316-a790-67b0f5512b722026-04-16Warnings, Adverse reactionsExact identifier
application number: ANDA078352
rxcui: 349420
unii: FVF865388R
CLARINEX-D 12 HOURDESLORATADINE AND PSEUDOEPHEDRINE SULFATEOrganon LLC1af66b7a-4ab8-40d8-abdd-22d3310228a82025-11-12Warnings, Adverse reactionsExact identifier
unii: FVF865388R
DesloratadineDESLORATADINEBryant Ranch Prepackcf7f838b-4595-4c81-97b9-e1594347e1bd2025-11-06Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
Desloratadine Oral SolutionDESLORATADINEINA Pharmaceutics, Inc.41d5e0d4-6188-847b-e063-6294a90a2e2f2025-10-23Warnings, Adverse reactionsExact identifier
unii: FVF865388R
DesloratadineDESLORATADINEVirtus Pharmaceuticals, LLC0fe374d0-c14b-4102-b568-eb79165fc7ef2025-07-10Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
ClarinexDESLORATADINEOrganon LLCc671342e-69a2-4ca5-abc2-8166ed4240d42025-05-17Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
DesloratadineDESLORATADINEDr. Reddy's Laboratories Limitede5d1f465-e436-b4fd-d351-07a7b2acb4402024-02-28Warnings, Adverse reactionsExact identifier
unii: FVF865388R
DesloratadineDESLORATADINEA-S Medication Solutions36307c2b-6b6a-46a9-9fe4-1798fc72e7b82023-12-12Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R
DesloratadineDESLORATADINEBionpharma Inc.4d094001-b85a-47b3-bc67-a46660384ece2023-11-27Warnings, Adverse reactionsExact identifier
rxcui: 349420
unii: FVF865388R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.